Newsletters

The European Medicines Agency (EMA) publishes newsletters to provide updates on various topics to patients, healthcare professionals and the pharmaceutical industry.
Human Veterinary Data on medicines Pharmacovigilance SME

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Human medicines highlights

Human medicines highlights, published monthly, contains key information on human medicines and changes to regulatory processes in the past month. These highlights do not cover all EMA's activities in the area of human medicines.

Issues from May 2024 (Issue 180) onwards are available at the link below:

Use this link to receive Human Medicines Highlights by email:

Select the expandable panel below to access previous issues:

Human medicines highlights - April 2024

Reference Number: Issue 179

English (EN) (325.35 KB - PDF)

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Human medicines highlights - March 2024

Reference Number: Issue 178

English (EN) (352.99 KB - PDF)

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Human medicines highlights - February 2024

Reference Number: Issue 177

English (EN) (236.57 KB - PDF)

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Human medicines highlights - January 2024

Reference Number: Issue 176

English (EN) (248.32 KB - PDF)

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Human medicines highlights - November-December 2023

Reference Number: Issue 175

English (EN) (387.8 KB - PDF)

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Human medicines highlights - October 2023

Reference Number: Issue 174

English (EN) (329.23 KB - PDF)

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Human medicines highlights - September 2023

Reference Number: Issue 173

English (EN) (274.2 KB - PDF)

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Human medicines highlights - August 2023

Reference Number: Issue 172

English (EN) (285.65 KB - PDF)

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Human medicines highlights - July 2023

Reference Number: Issue 171

English (EN) (301.12 KB - PDF)

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Human medicines highlights - June 2023

Reference Number: Issue 170

English (EN) (305.45 KB - PDF)

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Human medicines highlights - May 2023

Reference Number: Issue 169

English (EN) (371.05 KB - PDF)

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Human medicines highlights - April 2023

Reference Number: Issue 168

English (EN) (356.44 KB - PDF)

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Human medicines highlights - March 2023

Reference Number: Issue 167

English (EN) (340.59 KB - PDF)

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Human medicines highlights - February 2023

Reference Number: Issue 166

English (EN) (273.8 KB - PDF)

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Human medicines highlights - January 2023

Reference Number: Issue 165

English (EN) (339.17 KB - PDF)

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Human medicines highlights - December 2022

Reference Number: Issue 164

English (EN) (342.63 KB - PDF)

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Human medicines highlights - November 2022

Reference Number: Issue 163

English (EN) (284.79 KB - PDF)

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Human medicines highlights - September 2022

Reference Number: Issue 162

English (EN) (449.35 KB - PDF)

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Human medicines highlights - August 2022

Reference Number: Issue 161

English (EN) (347.93 KB - PDF)

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Human medicines highlights - July 2022

Reference Number: Isssue 160

English (EN) (274.83 KB - PDF)

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Human medicines highlights - June 2022

Reference Number: Isssue 159

English (EN) (278.67 KB - PDF)

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Human medicines highlights - April 2022

Reference Number: Isssue 157

English (EN) (262.57 KB - PDF)

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Human medicines highlights - March 2022

Reference Number: Issue 156

English (EN) (336.87 KB - PDF)

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Human medicines highlights - February 2022

Reference Number: Issue 155

English (EN) (277.2 KB - PDF)

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Human medicines highlights - January 2022

Reference Number: Issue 154

English (EN) (282.14 KB - PDF)

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Human medicines highlights - December 2021

Reference Number: Issue 153

English (EN) (279.74 KB - PDF)

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Human medicines highlights - November 2021

Reference Number: Issue 152 Summary:

This newsletter is addressed primarily to organisations representing patients, consumers and healthcare professionals. It provides a summary of key information relating to medicines for human use published during the previous month by the European Medicines Agency.

English (EN) (333.27 KB - PDF)

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Human medicines highlights - October 2021

Reference Number: Issue 151

English (EN) (336.35 KB - PDF)

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Human medicines highlights - September 2021

Reference Number: Issue 150

English (EN) (239.43 KB - PDF)

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Human medicines highlights - August 2021

Reference Number: Issue 149

English (EN) (330.45 KB - PDF)

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Human medicines highlights - July 2021

Reference Number: Issue 148

English (EN) (385.37 KB - PDF)

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Human medicines highlights - June 2021

Reference Number: Issue 147

English (EN) (399.25 KB - PDF)

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Human medicines highlights - May 2021

Reference Number: Issue 146

English (EN) (329.31 KB - PDF)

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Human medicines highlights - April 2021

Reference Number: Issue 145

English (EN) (481.79 KB - PDF)

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Human medicines highlights - March 2021

Reference Number: Issue 144

English (EN) (272.14 KB - PDF)

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Human medicines highlights - February 2021

Reference Number: Issue 143

English (EN) (453.49 KB - PDF)

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Human medicines highlights - January 2021

Reference Number: Issue 142 Summary:

This newsletter is addressed primarily to organisations representing patients, consumers and healthcare professionals. It provides a summary of key information relating to medicines for human use published during the previous month by the European Medicines Agency.

English (EN) (872.45 KB - PDF)

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Human medicines highlights - December 2020

Reference Number: Issue 141

English (EN) (774.63 KB - PDF)

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Human medicines highlights - November 2020

Reference Number: Issue 140

English (EN) (628.62 KB - PDF)

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Human medicines highlights - October 2020

Reference Number: Issue 139

English (EN) (674.99 KB - PDF)

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Human medicines highlights - September 2020

Reference Number: Issue 138

English (EN) (333.09 KB - PDF)

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Human medicines highlights - August 2020

Reference Number: Issue 137

English (EN) (621.19 KB - PDF)

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Human medicines highlights - July 2020

Reference Number: Issue 136

English (EN) (810.96 KB - PDF)

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Human medicines highlights - June 2020

Reference Number: Issue 135

English (EN) (606.29 KB - PDF)

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Human medicines highlights - May 2020

Reference Number: Issue 134

English (EN) (352.37 KB - PDF)

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Human medicines highlights - April 2020

Reference Number: Issue 133

English (EN) (282.67 KB - PDF)

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Human medicines highlights - March 2020

Reference Number: Issue 132

English (EN) (812.12 KB - PDF)

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Human medicines highlights - February 2020

Reference Number: Issue 131

English (EN) (488.32 KB - PDF)

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Human medicines highlights - January 2020

Reference Number: Issue 130

English (EN) (654.41 KB - PDF)

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Human medicines highlights - December 2019

Reference Number: Issue 129

English (EN) (442.81 KB - PDF)

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Human medicines highlights - November 2019

Reference Number: Issue 128

English (EN) (335.94 KB - PDF)

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Human medicines highlights - October 2019

Reference Number: Issue 127

English (EN) (355.34 KB - PDF)

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Human medicines highlights - September 2019

Reference Number: Issue 126

English (EN) (339.4 KB - PDF)

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Human medicines highlights - August 2019

Reference Number: Issue 125

English (EN) (396.97 KB - PDF)

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Human medicines highlights - July 2019

Reference Number: Issue 124

English (EN) (419.77 KB - PDF)

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Human medicines highlights - June 2019

Reference Number: Issue 123

English (EN) (352.18 KB - PDF)

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Human medicines highlights - May 2019

Reference Number: Issue 122

English (EN) (337.41 KB - PDF)

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Human medicines highlights - April 2019

Reference Number: Issue 121

English (EN) (372.19 KB - PDF)

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Human medicines highlights - March 2019

Reference Number: Issue 120

English (EN) (452.59 KB - PDF)

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Human medicines highlights - February 2019

Reference Number: Issue 119

English (EN) (389.08 KB - PDF)

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Human medicines highlights - January 2019

Reference Number: Issue 118

English (EN) (378.06 KB - PDF)

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EU Regulatory Oncology Newsletter

Issues from October 2024 onwards are available at the link below: 

Use this link to receive the EU Regulatory Oncology Newsletter by email:

Small and Medium-sized Enterprises (SMEs) Highlights

Issues from February 2024 (Issue 61) onwards are available at the link below: 

Use this link to receive Small and Medium-sized Enterprises (SMEs) Highlights by email:

Select the expandable panel below to access previous issues:

News bulletin for small and medium-sized enterprises - Issue 60

English (EN) (1.33 MB - PDF)

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News bulletin for small and medium-sized enterprises - Issue 59

English (EN) (1.09 MB - PDF)

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News bulletin for small and medium-sized enterprises - Issue 58

Reference Number: Issue 58

English (EN) (1.05 MB - PDF)

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News bulletin for small and medium-sized enterprises - Issue 57

Reference Number: Issue 57

English (EN) (1.04 MB - PDF)

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News bulletin for small and medium-sized enterprises - Issue 56

Reference Number: Issue 56

English (EN) (1.17 MB - PDF)

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News bulletin for small and medium-sized enterprises - Issue 55

Reference Number: Issue 55

English (EN) (1.28 MB - PDF)

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News bulletin for small and medium-sized enterprises - Issue 54

Reference Number: Issue 54

English (EN) (1.08 MB - PDF)

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News bulletin for small and medium-sized enterprises - Issue 53

Reference Number: Issue 53

English (EN) (1.59 MB - PDF)

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News bulletin for small and medium-sized enterprises - Issue 52

Reference Number: Issue 52

English (EN) (1.13 MB - PDF)

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News bulletin for small and medium-sized enterprises - Issue 51

Reference Number: Issue 51 Summary:

SME Newsletter - Issue 51

English (EN) (1.32 MB - PDF)

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News bulletin for small and medium-sized enterprises - Issue 50

Reference Number: Issue 50

English (EN) (537.38 KB - PDF)

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News bulletin for small and medium-sized enterprises - Issue 49

Reference Number: Issue 49

English (EN) (632.66 KB - PDF)

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News bulletin for small and medium-sized enterprises - Issue 48

Reference Number: Issue 48

English (EN) (643.01 KB - PDF)

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News bulletin for small and medium-sized enterprises - Issue 47

Reference Number: Issue 47

English (EN) (687.64 KB - PDF)

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News bulletin for small and medium-sized enterprises - Issue 46

Reference Number: Issue 46

English (EN) (1.09 MB - PDF)

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News bulletin for small and medium-sized enterprises - Issue 45

Reference Number: Issue 45

English (EN) (1016.05 KB - PDF)

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News bulletin for small and medium-sized enterprises - Issue 44

Reference Number: Issue 44 Summary:

Information for SMEs on the EU regulatory environment for medicines. Published four times a year by the European Medicines Agency.

English (EN) (580.16 KB - PDF)

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News bulletin for small and medium-sized enterprises - Issue 43

English (EN) (779.53 KB - PDF)

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News bulletin for small and medium-sized enterprises - Issue 42

Reference Number: Issue 42

English (EN) (1.35 MB - PDF)

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News bulletin for small and medium-sized enterprises - Issue 41

English (EN) (796.64 KB - PDF)

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News bulletin for small and medium-sized enterprises - Issue 40

English (EN) (1007.65 KB - PDF)

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News bulletin for small and medium-sized enterprises - Issue 39

Reference Number: Issue 39 Summary:

Information for SMEs on the EU regulatory environment for medicines. Published four times a year by the European Medicines Agency.

English (EN) (765.33 KB - PDF)

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News bulletin for small and medium-sized enterprises - Issue 38

English (EN) (771.39 KB - PDF)

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News bulletin for small and medium-sized enterprises - Issue 37

Reference Number: Issue 37 Summary:

Information for SMEs on the EU regulatory environment for medicines. Published four times a year by the European Medicines Agency.

English (EN) (488.74 KB - PDF)

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News bulletin for small and medium-sized enterprises - Issue 36

Reference Number: Issue 36

English (EN) (846.46 KB - PDF)

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News bulletin for small and medium-sized enterprises - Issue 35

English (EN) (802.95 KB - PDF)

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News bulletin for small and medium-sized enterprises - Issue 34

Reference Number: Issue 34 Summary:

Information for SMEs in the EU regulatory environment for medicines. Published four times a year by the European Medicines Agency.

English (EN) (597.34 KB - PDF)

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News bulletin for small and medium-sized enterprises - Issue 33

Reference Number: Issue 33 Summary:

Information for SMEs in the EU regulatory environment for medicines. Published four times a year by the European Medicines Agency.

English (EN) (807.15 KB - PDF)

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News bulletin for small and medium-sized enterprises - Issue 32

Reference Number: Issue 32 Summary:

Information for SMEs in the EU regulatory environment for medicines. Published four times a year by the European Medicines Agency.

English (EN) (412.12 KB - PDF)

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News bulletin for small and medium-sized enterprises - Issue 31

Reference Number: Issue 31

English (EN) (645.42 KB - PDF)

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News bulletin for small and medium-sized enterprises - Issue 30

Reference Number: Issue 30 Summary:

A reflection paper on the requirements for the selection and justification of starting materials in the manufacture of chemical active substances has been adopted.

English (EN) (559.72 KB - PDF)

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News bulletin for small and medium-sized enterprises - Issue 29

Reference Number: Issue 29 Summary:

Annex 6 to ICH guideline Q4B “Evaluation and Recommendation of pharmacopoeial texts for use in the ICH Regions” came into effect in June 2014.

English (EN) (434.49 KB - PDF)

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News bulletin for small and medium-sized enterprises - Issue 28

Reference Number: Issue 28 Summary:

A guideline on the declaration of the quantitative composition / potency labelling of biological medicinal products will come into effect on 1 September 2014 (EMA/CHMP/BWP/85290/2012).

English (EN) (553.51 KB - PDF)

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News bulletin for small and medium-sized enterprises - Issue 27

Reference Number: Issue 27 Summary:

A joint CHMP/CVMP guideline on process validation for finished products will come into effect on 15 June 2014 (EMA/CHMP/CVMP/QWP/BWP/70278/2012-Rev1).

English (EN) (504.77 KB - PDF)

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News bulletin for small and medium-sized enterprises - Issue 26

Reference Number: Issue 26

English (EN) (334.84 KB - PDF)

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News bulletin for small and medium-sized enterprises - Issue 25

Reference Number: Issue 25

English (EN) (362.65 KB - PDF)

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News bulletin for small and medium-sized enterprises - Issue 24

English (EN) (476.79 KB - PDF)

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News bulletin for small and medium-sized enterprises - Issue 23

English (EN) (316.89 KB - PDF)

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News bulletin for small and medium-sized enterprises - Issue 22

Summary:

This news bulletin is published four times a year by the SME Office of the European Medicines Agency.

The news bulletin aims to bring to the attention of SMEs, and their stakeholders, documents and activities related to the European regulatory environment.

English (EN) (529.78 KB - PDF)

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News bulletin for small and medium-sized enterprises - Issue 21

English (EN) (327.67 KB - PDF)

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News bulletin for small and medium-sized enterprises - Issue 20

Reference Number: Issue 20 Summary:

This news bulletin is published four times a year by the SME Office of the European Medicines Agency. The news bulletin aims to bring to the attention of SMEs, and their stakeholders, documents and activities related to the European regulatory environment.

English (EN) (351.11 KB - PDF)

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News bulletin for small and medium-sized enterprises - Issue 19

Summary:

This news bulletin is published four times a year by the SME Office of the European Medicines Agency.

The news bulletin aims to bring to the attention of SMEs, and their stakeholders, documents and activities

related to the European regulatory environment.

English (EN) (504.37 KB - PDF)

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News bulletin for small and medium-sized enterprises - Issue 18

Summary:

The news bulletin aims to bring to the attention of SMEs, and their stakeholders, ocuments and activities related to the European regulatory environment.

English (EN) (238.95 KB - PDF)

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News bulletin for small and medium-sized enterprises - Issue 17

Summary:

This news bulletin is published four times a year by the SME Office of the European Medicines Agency. The news bulletin aims to bring to the attention of SMEs, and their stakeholders, documents and activities related to the European regulatory environment.

English (EN) (414.45 KB - PDF)

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News bulletin for small and medium-sized enterprises - Issue 16

Summary:

This news bulletin is published four times a year by the SME Office of the European Medicines Agency.

English (EN) (602.4 KB - PDF)

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News bulletin for small and medium-sized enterprises - Issue 15

Summary:

This news bulletin is published four times a year by the SME Office of the European Medicines Agency.

The news bulletin aims to bring to the attention of SMEs, and their stakeholders, documents and activities related to the European regulatory environment.

English (EN) (353.32 KB - PDF)

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Clinical Trials Highlights

Issues from July 2023 (Issue 15) onwards are available at the link below: 

Use this link to receive Clinical Trials Highlights by email:

Select the expandable panel below to access previous issues:

Clinical Trials Highlights - April 2023

Reference Number: Issue 14

English (EN) (1023.34 KB - PDF)

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Clinical Trials Highlights - February 2023

Reference Number: Issue 13

English (EN) (1.63 MB - PDF)

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Clinical Trials Highlights - December 2022

Reference Number: Issue 12

English (EN) (1.15 MB - PDF)

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Clinical Trials Highlights - October 2022

Reference Number: Issue 11

English (EN) (706.31 KB - PDF)

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Clinical Trials Highlights - July 2022

Reference Number: Issue 10

English (EN) (864.72 KB - PDF)

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Clinical Trials Highlights - May 2022

Reference Number: Issue 9

English (EN) (520.75 KB - PDF)

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Clinical Trials Highlights - March 2022

Reference Number: Issue 8

English (EN) (546.63 KB - PDF)

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Clinical Trials Information System (CTIS) highlights - January 2022

Reference Number: Issue 7

English (EN) (543.39 KB - PDF)

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Clinical Trials Information System (CTIS) highlights - December 2021

Reference Number: Issue 6

English (EN) (677.31 KB - PDF)

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Clinical Trials Information System (CTIS) highlights - October 2021

Reference Number: Issue 5

English (EN) (615.7 KB - PDF)

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Clinical Trials Information System (CTIS) highlights - August 2021

Reference Number: Issue 4

English (EN) (521.49 KB - PDF)

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Clinical Trials Information System (CTIS) highlights - June 2021

Reference Number: Issue 3

English (EN) (1.03 MB - PDF)

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Clinical Trials Information System (CTIS) highlights - December 2020

Reference Number: Issue 2

English (EN) (979.81 KB - PDF)

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Clinical Trials Information System (CTIS) highlights - June 2020

Reference Number: Issue 1

English (EN) (1.52 MB - PDF)

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Veterinary Medicines Highlights

Issues from September 2023 (Issue 13) onwards are available at the link below: 

Use this link to receive Veterinary Medicines Highlights by email: 

Select the expandable panel below to access previous issues:

Veterinary Medicines Highlights - Issue 12

Reference Number: Issue 12

English (EN) (568.62 KB - PDF)

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Veterinary Medicinal Products Regulation highlights - Issue 11

Reference Number: Issue 11

English (EN) (674.83 KB - PDF)

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Veterinary Medicinal Products Regulation highlights - Issue 10

Reference Number: Issue 10

English (EN) (1.07 MB - PDF)

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Veterinary Medicinal Products Regulation highlights - Issue 9

Reference Number: Issue 9

English (EN) (1.05 MB - PDF)

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Veterinary Medicinal Products Regulation highlights - Issue 8

Reference Number: Issue 8

English (EN) (831.88 KB - PDF)

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Veterinary Medicinal Products Regulation highlights - Issue 7

Reference Number: Issue 7

English (EN) (843.44 KB - PDF)

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Veterinary Medicinal Products Regulation highlights - Issue 6

Reference Number: Issue 6 Summary:

News, views and interviews for the Veterinary Medicinal Products Regulation. Published every two months by the European Medicines Agency

English (EN) (1.2 MB - PDF)

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Veterinary Medicinal Products Regulation highlights - Issue 5

Reference Number: Issue 5

English (EN) (1.02 MB - PDF)

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Veterinary Medicinal Products Regulation highlights - Issue 4

Reference Number: Issue 4

English (EN) (1.2 MB - PDF)

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Veterinary Medicinal Products Regulation highlights - Issue 3

Reference Number: Issue 3

English (EN) (865.91 KB - PDF)

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Veterinary Medicines Regulation highlights - Issue 2

Reference Number: Issue 2

English (EN) (980.07 KB - PDF)

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Veterinary Medicines Regulation highlights - Issue 1

Reference Number: Issue 1 Summary:

News, views and interviews for the Veterinary Medicines Regulation. Published four times a year by the European Medicines Agency.

English (EN) (798.65 KB - PDF)

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Big Data Highlights

Issues from June 2023 (Issue 6) onwards are available at the link below: 

Use this link to receive Big Data Highlights by email: 

Select the expandable panel below to access previous issues from 2022: 

Big Data highlights - Issue 1

Reference Number: Issue 1

English (EN) (1.07 MB - PDF)

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Big Data highlights - Issue 2

Reference Number: Issue 2

English (EN) (1.29 MB - PDF)

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Big Data highlights - Issue 3

Reference Number: Issue 3

English (EN) (672.36 KB - PDF)

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Big Data highlights - Issue 4

Reference Number: Issue 4

English (EN) (936.3 KB - PDF)

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Big Data highlights - Issue 5

Reference Number: Issue 5

English (EN) (639.6 KB - PDF)

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Product Lifecycle Management Insights

Product Lifecycle Management Insights is available at the link below:

Use this link to receive Product Lifecycle Management Insights by email:

Clinical Trials Information System (CTIS) newsflash (discontinued)

EMA's ‘CTIS newsflash’ contains key updates on the latest developments, including system improvements, and links to useful reference materials.

From July 2025, the CTIS newsflash is replaced by Clinical Trials Highlights Newsletter.

CTIS newsflash – 24 June 2025

Reference Number: EMA/198062/2025

English (EN) (3.78 MB - PDF)

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CTIS newsflash - 10 June 2025

Reference Number: EMA/179146/2025

English (EN) (3.83 MB - PDF)

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CTIS newsflash - 27 May 2025

Reference Number: EMA/175583/2025

English (EN) (107.33 KB - PDF)

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CTIS newsflash - 16 May 2025

English (EN) (179.08 KB - PDF)

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CTIS newsflash - 29 April 2025

Reference Number: EMA/124649/2025

English (EN) (196.88 KB - PDF)

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CTIS newsflash - 25 March 2025

Reference Number: EMA/90566/2025

English (EN) (123.11 KB - PDF)

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CTIS newsflash - 11 March 2025

Reference Number: EMA/72075/2025

English (EN) (159.68 KB - PDF)

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CTIS newsflash - 25 February 2025

Reference Number: EMA/36861/2025

English (EN) (109.98 KB - PDF)

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CTIS newsflash – 11 February 2025

Reference Number: EMA/37270/2025

English (EN) (470.46 KB - PDF)

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CTIS newsflash – 28 January 2025

Reference Number: EMA/7145/2025

English (EN) (107.01 KB - PDF)

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CTIS newsflash - 14 January 2025

Reference Number: EMA/582910/2024

English (EN) (201.78 KB - PDF)

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CTIS newsflash - 17 December 2024

Reference Number: EMA/559561/2024

English (EN) (847.74 KB - PDF)

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CTIS newsflash - 3 December 2024

Reference Number: EMA/541301/2024

English (EN) (134.77 KB - PDF)

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CTIS newsflash - 19 November 2024

Reference Number: EMA/514303/2024

English (EN) (190.05 KB - PDF)

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CTIS newsflash - 5 November 2024

Reference Number: EMA/501426/2024

English (EN) (130.81 KB - PDF)

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CTIS newsflash - 22 October 2024

Reference Number: EMA/469994/2024

English (EN) (169.46 KB - PDF)

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CTIS newsflash - 8 October 2024

Reference Number: EMA/441928/2024

English (EN) (241.28 KB - PDF)

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CTIS newsflash - 24 September 2024

Reference Number: EMA/421508/2024

English (EN) (136.16 KB - PDF)

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CTIS newsflash - 10 September 2024

Reference Number: EMA/374537/2024

English (EN) (284.04 KB - PDF)

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CTIS newsflash - 9 August 2024

Reference Number: EMA/325160/2024

English (EN) (286.51 KB - PDF)

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CTIS newsflash - 26 July 2024

Reference Number: EMA/334159/2024

English (EN) (1.09 MB - PDF)

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CTIS newsflash - 12 July 2024

Reference Number: EMA/303545/2024

English (EN) (286.47 KB - PDF)

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CTIS newsflash - 28 June 2024

Reference Number: EMA/291916/2024

English (EN) (296.68 KB - PDF)

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CTIS newsflash – 14 June 2024

Reference Number: EMA/264069/2024

English (EN) (410.44 KB - PDF)

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CTIS newsflash - 31 May 2024

Reference Number: EMA/240597/2024

English (EN) (277.61 KB - PDF)

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CTIS newsflash - 17 May 2024

Reference Number: EMA/162262/2024

English (EN) (478.28 KB - PDF)

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CTIS newsflash – 3 May 2024

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CTIS newsflash - 22 April 2024

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CTIS newsflash - 26 January 2024

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CTIS newsflash – 12 January 2024

Reference Number: EMA/586501/2023

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CTIS newsflash – 22 December 2023

Reference Number: EMA/564292/2023

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CTIS newsflash - 8 December 2023

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CTIS newsflash – 24 November 2023

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CTIS newsflash – 10 November 2023

Reference Number: EMA/486111/2023

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CTIS newsflash – 27 October 2023

Reference Number: EMA/471461/2023

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CTIS newsflash – 13 October 2023

Reference Number: EMA/440825/2023

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CTIS newsflash - 29 September 2023

Reference Number: EMA/416454/2023

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CTIS newsflash - 15 September 2023

Reference Number: EMA/397022/2023

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CTIS newsflash - 1 September 2023

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CTIS newsflash – 18 August 2023

Reference Number: EMA/356297/2023

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CTIS newsflash - 4 August 2023

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CTIS newsflash - 21 July 2023

Reference Number: EMA/293653/2023

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CTIS newsflash - 7 July 2023

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CTIS newsflash – 23 June 2023

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CTIS newsflash - 9 June 2023

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Reference Number: EMA/220482/2023

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Reference Number: EMA/186032/2023

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Pharmacovigilance newsletter (discontinued)

'What's new in pharmacovigilance' provided regular updates on guidance, regulations and events. EMA has replaced this newsletter with targeted communications to qualified persons for pharmacovigilance (QPPV) as needed.

Select the expandable panel below to access all issues published between 2014 and 2019:

What’s new in pharmacovigilance - QPPV Update - Issue 1 - 2019

Reference Number: Issue 1 - 2019

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What’s new in pharmacovigilance - QPPV Update - Issue 2 - 2018

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What’s new in pharmacovigilance - QPPV Update - Issue 1 - 2018

Reference Number: Issue 1 Summary:

This qualified persons responsible for pharmacovigilance (QPPV) update provides QPPVs and all other people working in pharmacovigilance with an

update on European Union (EU) pharmacovigilance, relating to

medicines for human use.

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What's new in pharmacovigilance - QPPV Update - Issue 3 - 2017

Reference Number: Issue 3 - 2017

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What's new in pharmacovigilance - QPPV Update - Issue 2 - 2017

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What's new in pharmacovigilance - QPPV Update - Issue 1 - 2017

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What's new in pharmacovigilance - QPPV Update - Issue 3

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What's new in pharmacovigilance - QPPV Update - Issue 2

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What's new in pharmacovigilance - QPPV Update - Issue 1

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News bulletin for pharmacovigilance programme update - Issue 6

Reference Number: Issue 6 Summary:

News bulletin for pharmacovigilance programme update

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News bulletin for pharmacovigilance programme update - Issue 5

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News bulletin for pharmacovigilance programme update - Issue 4

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News bulletin for pharmacovigilance programme update - Issue 3

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News bulletin for pharmacovigilance programme update - Issue 2

Reference Number: Issue 2 Summary:

This second Pharmacovigilance Programme Update is primarily aimed at providing marketing authorisation holders (MAHs) with information to help prepare for the business change to come.

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News bulletin for pharmacovigilance programme update - Issue 1

Reference Number: Issue 1 Summary:

This Update is the first in a series of documents primarily aimed at providing marketingauthorisation holders (MAHs) with information on the development of the enhanced systems, helping MAHs prepare for the business change to

come.

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Electronic Application Form (eAF) - Product Management Service (PMS) newsletter (discontinued)

EMA discontinued the electronic Application Form (eAF) - Product Management Service (PMS) newsletter in 2023.

News on the eAF and PMS products can be found in the newsletter Product Lifecycle Management Insights.

For more information on PLM and PMS, please see:

Select the expandable panel below to access the issues published between 2022 and 2023:

Electronic Application Form (eAF) - Product Management Service (PMS) newsletter - Issue 3

Reference Number: Issue 3

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Electronic Application Form (eAF) newsletter - Issue 2

Reference Number: Issue 2

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Digital Application Dataset Integration (DADI) newsletter - Issue 1

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